# K904255: Focus T41,T41F,T43, T43F,T44F

- Pathway: 510(k) (Traditional)
- Applicant: Elamedical
- Decided: Jan 18, 1991 after 123 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (2000), 0 descendants of its own
- K963738: Stela Model BJ44 and BJ45 Pacing Leads (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K904255
Methodology: https://510kreport.com/methodology